510(k) · Cleared
Recalled · Class II · 2013Nxstage Pureflow-B Solution
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nxstage Medical, Inc. · KPO Dialysate Concentrate For Hemodialysis (Liquid Or Powder)
Cleared on Aug 27, 2004 as substantially equivalent to K033386 (Nxstage Medical, Inc., 2003) after a 28-day review. Its family tree reaches back 4 generations to 1987. 8 later devices descend from it. It has been recalled once.
- Decided
- Aug 27, 2004
- Review
- 28 days
- Class
- Class II
- Product code
- KPO
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 4 generations to K864265 (1987). 8 ancestors in all. 8 later devices descend from it, 2 citing it directly.
- Root · 4 generations backK864265 Hemodialysis Bath Concentrate Solutions for HemodiDial Medical of Florida, Inc. · 1987
- 3 generations backK013448 PrismasateGambro Renal Products · 2002
- 2 generations backK022913 Nxstage Premixed DialysateNxstage Medical, Inc. · 2002
- 1 generation backK033386 Nxstage Pureflow SolutionNxstage Medical, Inc. · 2003
- This deviceK042045 Nxstage Pureflow-B SolutionNxstage Medical, Inc. · 2004
- Descendant · cites it directly · 6 of its ownK072908 Prismasate Dialysis Solutions for Continuous Renal Replacement TherapyGambro Renal Products · 2008 · Recalled
- Descendant · 2 generations on · 5 of its ownK120333 Prismasate Dialysis Solutions for Continuius Renal Replacement TherapyGambro Renal Products · 2012
- Descendant · 2 generations on · 4 of its ownK162887 PrismaSATEBaxter Healthcare Corporation · 2017
- Descendant · 3 generations on · 3 of its ownK233159 pureFLOW 402, pureFLOW 400, pureFLOW 406, pureFLOW 401, pureFLOW…Fresenius Medical Care Renal Therapies Group, LLC · 2023
- Descendant · 4 generations on · 2 of its ownK233950 pureFLOW 402 (F00012067); pureFLOW 406 (F00012068); pureFLOW 401…Fresenius Medical Care Renal Therapies Group, LLC · 2024 · Recalled
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K072908Prismasate Dialysis Solutions for Continuous Renal Replacement TherapyGambro Renal Products · 2008 · cites it directly6descendants
- K120333Prismasate Dialysis Solutions for Continuius Renal Replacement TherapyGambro Renal Products · 2012 · 2 generations on5descendants
- K162887PrismaSATEBaxter Healthcare Corporation · 2017 · 2 generations on4descendants
- K233159pureFLOW 402, pureFLOW 400, pureFLOW 406, pureFLOW 401, pureFLOW 502, pureFLOW 504Fresenius Medical Care Renal Therapies Group, LLC · 2023 · 3 generations on3descendants
- K233950pureFLOW 402 (F00012067); pureFLOW 406 (F00012068); pureFLOW 401 (F00012069); pureFLOW…Fresenius Medical Care Renal Therapies Group, LLC · 2024 · 4 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K864265 | Hemodialysis Bath Concentrate Solutions for Hemodi | Dial Medical of Florida, Inc. | 1987 | — |
| −3 | K013448 | Prismasate | Gambro Renal Products | 2002 | — |
| −2 | K022913 | Nxstage Premixed Dialysate | Nxstage Medical, Inc. | 2002 | — |
| −1 | K033386 | Nxstage Pureflow Solution | Nxstage Medical, Inc. | 2003 | — |
| 0 (this device) | K042045 | Nxstage Pureflow-B Solution | Nxstage Medical, Inc. | 2004 | — |
| +1 | K072908 | Prismasate Dialysis Solutions for Continuous Renal Replacement Therapy | Gambro Renal Products | 2008 | 1 |
| +2 | K120333 | Prismasate Dialysis Solutions for Continuius Renal Replacement Therapy | Gambro Renal Products | 2012 | — |
| +2 | K162887 | PrismaSATE | Baxter Healthcare Corporation | 2017 | — |
| +3 | K233159 | pureFLOW 402, pureFLOW 400, pureFLOW 406, pureFLOW 401, pureFLOW 502, pureFLOW… | Fresenius Medical Care Renal Therapies Group, LLC | 2023 | — |
| +4 | K233950 | pureFLOW 402 (F00012067); pureFLOW 406 (F00012068); pureFLOW 401 (F00012069)… | Fresenius Medical Care Renal Therapies Group, LLC | 2024 | 1 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2008 | 1 | 0 |
| 2012 | 1 | 0 |
| 2017 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 2 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in KPO? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new KPO device
- #1 K233159 pureFLOW 402, pureFLOW 400, pureFLOW 406…score 14.5 · 8 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K033386 | Nxstage Pureflow SolutionSummary page 2…has been performed to ensure that the modified device meets design specifications. The modified NxStage PureFlow Solution has been compared to the baseline as cleared in K033386 and found to be substantially equivalent. Conclusion: Based on the device indications for use, comparison of descriptive and tec… | 2003 |
What descends from it? (8)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Mar 18, 2013 | Class II | Z-1214-2013 | Labeling mix-ups | Product may be mislabeled. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 17 years and passes through 3 companies; a new generation was cleared every 1.1 years on median.
- None of the 8 ancestors has a recall.
- Of its descendants, K072908 (Gambro Renal Products, 2008) has gone furthest, with 6 descendants of its own.
- 1 other device also cites its predicate K033386.
How does its category compare?
All KPO devicesKPO Dialysate Concentrate For Hemodialysis (Liquid Or Powder): FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · KPO
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · KPO
112in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KPO
6in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KPO
95in 2025
MAUDE reports naming product code KPO, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 2 | — | 5 | 5 |
| 2008 | 2 | — | 2 | 8 |
| 2009 | 1 | — | 1 | 3 |
| 2010 | 0 | — | 0 | 107 |
| 2011 | 1 | — | 2 | 223 |
| 2012 | 2 | — | 10 | 70 |
| 2013 | 1 | — | 0 | 3,897 |
| 2014 | 2 | — | 0 | 15,916 |
| 2015 | 1 | — | 3 | 8,340 |
| 2016 | 1 | — | 1 | 240 |
| 2017 | 3 | 192 | 1 | 80 |
| 2018 | 2 | — | 11 | 97 |
| 2019 | 0 | — | 1 | 79 |
| 2020 | 5 | 270 | 31 | 244 |
| 2021 | 1 | — | 0 | 63 |
| 2022 | 2 | — | 2 | 25 |
| 2023 | 3 | 263 | 0 | 59 |
| 2024 | 3 | 112 | 1 | 259 |
| 2025 | 2 | — | 6 | 95 |
| 2026 | 2 | — | 9 | — |
What is it indicated for?
NxStage PureFlow-B Solution is indicated for use with renal replacement therapy systems that utilize sterile premixed dialysate.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K042045 · printed Nov 4, 2026
Cite this page
510(k) Report. “K042045: Nxstage Pureflow-B Solution.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K042045
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026